CSV Engineer/Analyst

3 weeks ago

Fishers, United States Entegee Full time
Job DescriptionJob Description

Summary: Seeking a skilled Computer System Validation (CSV) Specialist to support commissioning and qualification efforts for a cell therapy manufacturing project.

  • Bachelor's degree in Engineering, Computer Science, or Life Sciences

  • 5+ years experience in CSV within GMP-regulated environments

  • Strong knowledge of FDA regulations and cGMP standards

  • Experience with DeltaV control systems and document management systems

Preferred Skills:

  • Experience in pharmaceuticals or biotechnology industries

Responsibilities:

  • Develop and execute CSV protocols (IQ, OQ, PQ) for manufacturing equipment

  • Collaborate with automation and validation teams to ensure compliance

  • Manage document lifecycle in compliance with project systems

  • Participate in weekly project meetings for alignment on needs and issue resolution

  • Conduct risk assessments and manage deviations for compliance reports

  • Oversee vendor interactions and track deliverables



Pay Details: $31.00 to $42.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance
Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.

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